The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation - Full Text View

Purpose

Fifty patients will get probiotics (109 bacteria [L. acidophilus, B. bifidum, S. thermophilus, L. rhamnosus, L. casei] in 2 capsules) and half will get placebo (2 capsules that look the same like the probiotic capsules and will contain microcrystalline cellulose, artificial brown color, magnesium strearate, and silica dioxide). The patients and the staff will be blinded to the identity of the study medications.

Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.

Each individual will be studied for changes in biochemical inflammatory and immunological markers and changes in flow medicated diameter that will be measured by the brachial artery method (that is evaluating endothelial function). Every patient will be evaluated for his/her ability to produce endothelial progenitor stem cells (EPCs).

Condition	Intervention	Phase
Crohn's Disease Ulcerative Colitis	Dietary Supplement: probiotics Dietary Supplement: placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	The Effect of Probiotics on Bowel Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease ulcerative colitis

MedlinePlus related topics: Crohn's Disease Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by The Baruch Padeh Medical Center, Poriya:

Primary Outcome Measures:

Truelove and Witts Classification of Ulcerative Colitis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Crohn's disease activity index (CDAI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	December 2012
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Intervention Details:

Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with ulcerative colitis and crohns' disease

Exclusion Criteria:.

notable caveats are that arteries smaller than 2.5 mm

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078935

Contacts

Contact: Arnon Blum, DR

972466522688

ablum@poria.health.gov.il

Sponsors and Collaborators

The Baruch Padeh Medical Center, Poriya

Ministry of Health, Israel

More Information

No publications provided

Responsible Party:	Arnon Blum, The baruch pade medical center, Poriya
ClinicalTrials.gov Identifier:	NCT01078935 History of Changes
Other Study ID Numbers:	Prob-bl.CTIL
Study First Received:	March 1, 2010
Last Updated:	August 10, 2011
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by The Baruch Padeh Medical Center, Poriya:

Crohn's disease activity index
CDAI

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013